Research Institute for Biological Safety Problems, Gvardeysk, Kazakhstan.
Influenza Research Institute, St.Petersburg, Russian Federation.
J Med Virol. 2017 Jul;89(7):1168-1173. doi: 10.1002/jmv.24771. Epub 2017 Mar 28.
The paper describes the results of preclinical testing of the preparation "Vaccine allantoic split-virus inactivated against seasonal influenza." Acute toxicity and local irritating effect, anaphylactic reactions to different antigens (vaccine and ovalbumin), delayed-type hypersensitivity to ram erythrocytes, humoral immune response in hemaggtination reaction, immunogenic activity was studied in laboratory animals of various species (mice, rats, guinea pigs). Comparative analysis of the results from testing immunogenic activity of the preparation under study and the commercial influenza vaccines was performed. The preclinical testing has demonstrated safety and immune response of the seasonal split influenza vaccine, so it may be recommended for clinical study on limited contingent of volunteers.
本文描述了制剂“抗季节性流感鸡胚分裂病毒灭活疫苗”的临床前测试结果。在不同的动物物种（小鼠、大鼠、豚鼠）的实验动物中，研究了制剂的急性毒性和局部刺激性作用、对不同抗原（疫苗和卵清蛋白）的过敏反应、对兔红细胞的迟发型超敏反应、血凝反应中的体液免疫反应、免疫原性活性。对所研究制剂的免疫原性活性的测试结果与商业流感疫苗进行了比较分析。临床前测试表明，季节性流感裂解疫苗具有安全性和免疫反应性，因此可以推荐在有限数量的志愿者中进行临床研究。
